Generic Rheumatoid Arthritis Drugs Just as Effective as Enbrel

With the costs of medications continually on the rise, the results of a new study should be welcome news for sufferers of rheumatoid arthritis (RA).

A report published in the New England Journal of Medicine(NEJM)found that patients who took a three drug regimen using oral generic drugs saw just as much improvement in their symptoms as those who underwent a costlier biologic treatment using Enbrel, an injectable brand name drug sold by Amgen (NASDAQ: AMGN).

“We compared two different ways of treating rheumatoid arthritis — one that included a new biologic [medication] with an older, more conventional oral medication,” researcher Dr. Ted Mikuls, an associate professor at the University of Nebraska Medical Center, in Omaha told HealthDay.

“We basically showed that at the end of the day patients, regardless of what they got, looked very similar in terms of pretty much every outcome we looked at in the study.”

The average annual cost of the three drug therapy is about $1,000, compared to about $25,000 per year for Enbrel, said Dr. James O’Dell, the lead study author and chief of rheumatology at the Omaha VA Medical Center in Nebraska . In 2012, global sales of Enbrel exceeded $4 billion for Amgen.

The triple therapy of generic drugs included a combination of methotrexate, sulfasalazine (Azulfidine) and hydroxychloroquine (Plaquenil). The more expensive treatment combined methotrexate with Enbrel.

“This study suggests clinicians ought to think about using combinations of traditional drugs before they go on to biologics in certain patients,” said O’Dell.

Rheumatoid arthritis is an autoimmune disease that causes inflammation in the joints, resulting in swelling, stiffness, pain and reduced joint function. According to the Centers for Disease Control and Prevention, RA affects an estimated 1.5 million Americans.

Methotrexate is one of the most effective and commonly used medicines in the treatment of arthritis and other rheumatic conditions. It is known as a disease-modifying anti-rheumatic drug because it not only decreases the pain and swelling of arthritis, but can also decrease joint damage and lower the risk of long-term disability.

About 20 to 40 percent of patients don’t respond to methotrexate or have side effects. RA patients usually aren’t switched to biologic injectable drugs unless treatment with methotrexate alone is ineffective.

The NEJM article noted that few blinded trials have compared RA treatment with disease-modifying anti-rheumatic drugs to that with biologic agents.

The 48-week, double-blind study randomly assigned 353 patients with rheumatoid arthritis to a triple regimen of disease-modifying anti-rheumatic drugs or Enbrel (etanercept) plus methotrexate. Some patients switched from one regimen to another midway through the study.

Researchers say that both groups had significant improvement with no difference between the two treatments. The reported improvements included pain relief, quality of life, and progression of arthritis as seen on X-rays.

“This study addresses a real-life scenario for rheumatologists where patients are often on methotrexate and are not doing well and the question is what to do next,” Dr. Soumya Reddy, an assistant professor in the rheumatology at NYU Langone Medical Center, told HealthDay.

She added that the findings are “reassuring,” in that when a biologic is not an option due to cost or other reasons, the older regimen is effective.

“Newer isn’t always better,” said Dr. Mikuls. “Some of the older medications can be effective.”

In an editorial also published in the NEJM, Joan Bathon, MD, and Donald J. McMahon, MS, questioned whether the cheaper generic treatment of RA would be adopted by physicians and insurance companies.

“We have to consider, however, whether these findings have arrived too late to influence modern practice”, they wrote. “Whether third-party payers who currently require failure of methotrexate monotherapy before prescription of expensive biologic therapy will change this policy to require failure of the cheaper nonbiologic combination is an interesting question.”

“We hope that with the ever-increasing number of effective treatments for rheumatoid arthritis, future recommendations for treatment will be guided by additional comparative-effectiveness studies such as the study by O’Dell et al.”